Clinical Decision Support for Unsolicited Genomic Results

项目总结 因为越来越多的健康个体可以接受基因组检测结果，这些结果表明他们有可能出现不良结局 (例如，疾病或药物不良反应)，医疗保健提供者需要确保结果得到处理 审慎地处理收到结果、工作流程挑战和责任问题。鉴于这一临床情况 基因组测试可以在临床环境之外(例如，在研究研究中)从临床医生的 从角度来看，它们可以被描述为主动获得的基因组结果(UGR)。临床决策支持(CDS) 通过向临床医生提供建议和与患者相关的建议，极有可能简化UGR的采用 在特定时间提供的信息，以加强临床护理。在医疗保健环境中为UGR部署CDS 然而，在可扩展的方式中，将取决于我们利用当地机构政策和监督的能力 批准CDS指南和UGR战略的结构。这项研究计划的具体目标 是开发和评估循证决策支持随时间执行(EDIT)模型 用于确定已部署的CDS for UGR的优先顺序并进行修订。编辑模式将赋予地方监督委员会权力 例如药房和治疗委员会在CDS审查和部署过程中发挥作用 在现有机构社会系统内使用公认的组织程序。这样做的直接好处是 工作将是一个编辑仪表板，监督委员会可以使用它来确定新的优先顺序和修改 部署了CDS和基础设施，通过传输CDS修订版来关闭学习健康系统的环路 经监督委员会成员批准部署用于UGR的CDS。编辑模型实现将是 混合方法研究策略：策略1，我们将在监督下进行焦点小组 委员会成员，以便了解委员会目前的作用、任务和目标，以及 关于确定、审查和批准UGR新的和修订的CDS的最佳程序的意见，作为 委员会会议活动。研究策略2，我们将对患者进行调查研究，以评估 与监督委员会成员一起收集对UGR返回CDS和可用性研究的偏好 对编辑仪表板设计的反馈。策略3，我们将对地方监督进行时间运动观测 在部署编辑模型之前和之后的委员会会议，以便规划未来、多机构、时间- 具有统计能力的动议研究，可检测使用编辑的监督委员会之间的差异 仪表板和不支持仪表板的设备。假设花费在区分新的和修订的CDS的优先顺序上的时间将是 使用编辑仪表板可缩短显示时间。总体而言，编辑模型建立了降低门槛的流程 实施强大的基因组医学计划，其他人可以效仿。基因组创新者奖 将使我能够在团队科学项目中研究编辑模式如何加速机构审查 以及UGR的CDS审批流程。这项工作的更广泛的影响是能够研究UGR率 医疗保健提供商采用针对UGR部署的CDS。

PROJECT SUMMARY As healthy individuals increasingly can receive genomic testing results that indicate their risk for poor outcomes (e.g. diseases or adverse drug reactions), healthcare providers will need to ensure that the results are handled prudently, by addressing the receipt of the results, the workflow challenges, and liability issues. Given that clinical genomic tests can be initiated outside of the clinical setting (e.g., in a research study), from the clinician’s perspective, they can be characterized as unsolicited genomic results (UGR). Clinical decision support (CDS) has great potential to ease the adoption of UGR by providing clinicians with recommendations and patient-related information presented at particular times to enhance clinical care. Deploying CDS for UGR in a healthcare setting in a scalable way, however, will depend on our capacity to leverage local institutional policy and oversight structures to approve of CDS guidance and strategies for UGR. The specific objective of this research program is to develop and evaluate the Evidence-based Decision support Implementation over Time (EDIT) model for prioritizing and revising deployed CDS for UGR. The EDIT model will empower local oversight committees such as Pharmacy & Therapeutics committees to have a role in the CDS review and deployment processes within existing institutional social systems using accepted organizational processes. The direct benefits of this work will be an EDIT dashboard that can be used by oversight committees to prioritize new and to revise deployed CDS, and infrastructure to close the loop of the learning health system by transferring CDS revisions approved by oversight committee members into deployed CDS for UGR. EDIT model implementation will be informed by mixed methods research strategies: Strategy 1, we will conduct focus groups with oversight committee members in order to understand current roles, tasks and goals of the committee, as well as to capture opinions about the best processes to prioritize, review and approve of new and revised CDS for UGR as part of committee meeting activities. Research Strategy 2, we will conduct a survey study with patients to assess preferences for the return of UGR with CDS and usability studies with oversight committee members to gather feedback on the EDIT dashboard design. Strategy 3, we will conduct time-motion observations of local oversight committee meetings prior to and after deploying the EDIT model in order to plan a future, multi-institution, time- motion study with statistical power to detect differences between oversight committees that use the EDIT dashboard and those that do not. The hypothesis is that time spent prioritizing new and revised CDS will be shorter with use of the EDIT dashboard. Overall, the EDIT model establishes processes that lower barriers to implementing robust genomic medicine programs that can be followed by others. The Genomic Innovator Award will enable me to study, in team-science projects, how the EDIT model can accelerate the institutional review and approval process of CDS for UGR. The broader impact of this work is being able to study rate of UGR adoption by healthcare providers for deployed CDS for UGR.